Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia

Cumberland Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Hyponatremia

Treatments: Drug: YM087 oral

Study type: Interventional

Funder types: Industry

Identifiers

NCT00492037

087-CL-043

1025-023

Details and patient eligibility

About

Study of efficacy & safety of oral YM087 in subjects with euvolemic or hypervolemic hyponatremia

Enrollment: 83 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Serum Sodium 115 to <130mEq/L
• Plasma Osmolarity <290 mOsmol/kg H2O

Exclusion criteria

• Significant renal insufficiency
• Serum sodium increase of ≥8 mEq/L over the baseline day ( Hours 0 to 12)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind